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Basiliximab Side Effects

For the Consumer

Applies to basiliximab: intravenous powder for solution

In addition to its needed effects, some unwanted effects may be caused by basiliximab. In the event that any of these side effects do occur, they may require medical attention.

Severity: Moderate

If any of the following side effects occur while taking basiliximab, check with your doctor or nurse as soon as possible:

More common:
  • Abdominal pain
  • back pain
  • coughing
  • dizziness
  • fever or chills
  • loss of energy or weakness
  • painful urination
  • shortness of breath
  • sore throat
  • swelling of the ankles, body, face, feet or lower legs
  • trembling or shaking of the hands or feet
  • vomiting
  • white patches in the mouth or throat or on the tongue
Less common:
  • Abnormal vision
  • agitation
  • anxiety
  • bleeding, tender, or enlarged gums
  • blood in the stool
  • bruising
  • chest pain
  • depression
  • difficulty in urinating
  • fatigue
  • itching
  • numbness or pain in the legs
  • skin rash
  • sores in the mouth
  • “stocking and gloves” sensation of the hands or feet
  • tingling

Minor Side Effects

Some of the side effects that can occur with basiliximab may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Acne
  • constipation
  • diarrhea
  • headache
  • heartburn
  • nausea
  • trouble in sleeping
  • weight gain
Less common:
  • Excessive hair growth
  • joint pain
  • muscle pain

For Healthcare Professionals

Applies to basiliximab: intravenous powder for injection

Gastrointestinal

Gastrointestinal side effects have been reported in 75% of treated patients (vs 73% in placebo treated patients), making them the most frequently reported side effect with the use of basiliximab. Other gastrointestinal effects including constipation, nausea, diarrhea, abdominal pain, vomiting, dyspepsia, and moniliasis have been reported in at least 10% of patients. Enlarged abdomen, flatulence, gastrointestinal disorder, gastroenteritis, GI hemorrhage, gum hyperplasia, melena, esophagitis, and ulcerative stomatitis have been reported in between 3% and 10% of patients.[Ref]

Hypersensitivity

Hypersensitivity side effects including seventeen cases of severe acute hypersensitivity reactions (including anaphylaxis) have been reported. Reactions may include hypotension, tachycardia, cardiac failure, dyspnea, wheezing, bronchospasm, pulmonary edema, respiratory failure, urticaria, rash, pruritus, and/or sneezing.[Ref]

If a severe hypersensitivity reaction occurs, it is recommended that therapy with basiliximab be permanently discontinued.[Ref]

Metabolic

Metabolic side effects including hyperkalemia, hypokalemia, hyperglycemia, hyperuricemia, hypophosphatemia, hypocalcemia, weight increase, hypercholesterolemia, and acidosis have been reported in at least 10% of patients. Dehydration, diabetes mellitus, fluid overload, hypercalcemia, hyperlipidemia, hypoglycemia, hypoproteinemia, and hypomagnesemia have been reported in between 3% and 10% of patients.[Ref]

Nervous system

Nervous system side effects including headache, tremor, and dizziness have been reported in at least 10% of patients. Hypoesthesia, neuropathy, and paraesthesia have been reported in between 3% and 10% of patients.[Ref]

Genitourinary

Genitourinary side effects including dysuria, increased nonprotein nitrogen, and urinary tract infection have been reported in at least 10% of patients. Male genital edema, impotence, albuminuria, bladder disorder, hematuria, frequent micturition, oliguria, abnormal renal function, renal tubular necrosis, surgery, urethral disorder, and urinary retention have been reported in between 3% and 10% of patients.[Ref]

General

General side effects including pain, peripheral edema, edema, fever, viral infection, leg edema, and asthenia have been reported in at least 10% of patients. Accidental trauma, chest pain, increased drug level, face edema, fatigue, infection, malaise, generalized edema, rigors, and sepsis have been reported in between 3% and 10% of patients.[Ref]

Cardiovascular

Cardiovascular side effects including hypertension have been reported in at least 10% of patients. Angina pectoris, cardiac failure, chest pain, abnormal heart sounds, aggravated hypertension, arrhythmia, atrial fibrillation, tachycardia, vascular disorder, and hypotension have been reported in between 3% and 10% of patients.[Ref]

Respiratory

Respiratory side effects including dyspnea, upper respiratory tract infection, coughing, rhinitis, and pharyngitis have been reported in at least 10% of patients. Bronchitis, bronchospasm, abnormal chest sounds, pneumonia, pulmonary disorder, pulmonary edema, and sinusitis have been reported in between 3% and 10% of patients.[Ref]

Dermatologic

Dermatologic side effects including surgical wound complications and acne have been reported in at least 10% of patients. Cyst, herpes simplex, herpes zoster, hypertrichosis, pruritus, rash, skin disorder, and skin ulceration have been reported in between 3% and 10% of patients.[Ref]

Psychiatric

Psychiatric side effects including insomnia have been reported in at least 10% of patients. Agitation, anxiety, and depression have been reported in between 3% and 10% of patients.[Ref]

Musculoskeletal

Musculoskeletal side effects including leg pain and back pain have been reported in at least 10% of patients. Arthralgia, arthropathy, bone fractures, cramps, hernia, and myalgia have been reported in between 3% and 10% of patients.[Ref]

Hematologic

Hematologic side effects including anemia have been reported in at least 10% of patients. Hematoma, hemorrhage, purpura, thrombocytopenia, polycythemia, and thrombosis have been reported in between 3% and 10% of patients.[Ref]

Endocrine

Endocrine side effects including increased glucocorticoids have been reported in between 3% and 10% of patients.[Ref]

Ocular

Ocular side effects including cataract, conjunctivitis, and abnormal vision have been reported in between 3% and 10% of patients.[Ref]

References

1. "Product Information. Simulect (basiliximab)." Novartis Pharmaceuticals, East Hanover, NJ.

Not all side effects for basiliximab may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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